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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Fixation Cerclage, Sublaminar
510(k) Number K110348
Device Name UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
Applicant
Zimmer Spine
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact ELSA A LINKE
Correspondent
Zimmer Spine
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact ELSA A LINKE
Regulation Number888.3010
Classification Product Code
OWI  
Date Received02/07/2011
Decision Date 08/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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